Cleared Traditional

K934981 - DENTAL DRILL

K934981 is an FDA 510(k) clearance for DENTAL DRILL, manufactured by Eare Consulting Service. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K934981 · Eare Consulting Service · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
107d
Days
Class 1
Risk

K934981 is an FDA 510(k) clearance for the DENTAL DRILL. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on February 3, 1994 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Eare Consulting Service devices

FDA 510(k) Submission Details - K934981

510(k) Number K934981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date February 03, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZP Instrument, Diamond, Dental

Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K934981.
DENDIA WERK BURS AND CUTTING DISCS
K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
HYBRID POINTS
K854347 · Shofu Dental Corp. · Dec 1985
GINGI CURETTAGE DIAMOND POINTS
K832856 · Shofu Dental Corp. · Oct 1983
SUMMA DISK
K833038 · Shofu Dental Corp. · Oct 1983
TPE DIAMOND POINTS
K832855 · Shofu Dental Corp. · Sep 1983